Cleared Traditional

MiniMed Go App

K253512 · Medtronic Minimed · Chemistry
Jan 2026
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K253512 is an FDA 510(k) clearance for the MiniMed Go App, a Calculator, Drug Dose (Class II — Special Controls, product code NDC), submitted by Medtronic Minimed (Los Angeles, US). The FDA issued a Cleared decision on January 8, 2026, 63 days after receiving the submission on November 6, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K253512 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2025
Decision Date January 08, 2026
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NDC — Calculator, Drug Dose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890